MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the gz transmitter batteries were draining within two (2) hours and the device did not give an alarm indicating the battery was low.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the gz transmitter batteries were draining within two (2) hours and the device did not give an alarm indicating the battery was low.They stated the batteries were new and had the same settings as a working gz transmitter.No reports of patient harm or injuries.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Attempt # 1: 07/18/2023 emailed the bme for patient information and the concomitant medical device: no reply was received.Attempt # 2: 07/21/2023 emailed the bme for patient information and the concomitant medical device: no reply was received.Attempt # 3: 07/24/2023 emailed the bme for patient information and the concomitant medical device: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz transmitter batteries were draining within two (2) hours and the device did not give an alarm indicating the battery was low.They stated the batteries were new and had the same settings as a working gz transmitter.No reports of patient harm or injuries.Investigation summary: nihon kohden received the device on 07/28/2023.Nk repair center evaluated the device on 10/23/2023 and duplicated the complaint.The unit was tested with two new batteries, and it drained fast.Nk rc found that the battery contacts were corroded and the ecg and spo2 ports were dirty.Based on the device evaluation, the cause of the issue was a lack of proper maintenance of the transmitter.The gz-130p operator's manual states that if the device is not going to be used for an extended period, the user should remove the batteries before storing the device to prevent battery leakage.A review of the complaint device's serial number shows no other complaint.A review of the customer's complaint history did not reveal any trends.Nk will continue to monitor and trend similar complaints.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter:.

Event Description

The biomedical engineer (bme) reported that the gz transmitter batteries were draining within two (2) hours and the device did not give an alarm indicating the battery was low.No patient harm was reported.

• Brand Name: GZ-130PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17386109
• MDR Text Key: 320125595
• Report Number: 8030229-2023-03685
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GZ-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS; CNS